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HEARTSINE TECHNOLOGIES LTD

US

Last updated May 30, 2026

Information

Country
US
Address
—
Website
stryker.com
LinkedIn
—
Facebook
—
Phone
+1(215)860-8100
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
230479318

Catalogue (35)

DeviceModel / ReferenceRegistriesClassStatus
HeartSine Samaritan PAD 450P SAM450P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 350P SAM 350P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 360P SAM 360P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 450P SAM450P
FDA UDI
Class IIIActive
samaritan PAD SAM360P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 360P SAM 360P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 360P SAM 360P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 350P SAM 350P
FDA UDI
Class IIIActive
Pad-Pak Pad-Pak-01
FDA UDI
Class IIIActive
Pad-Pak Pad-Pak-07
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 450P SAM 450P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 350P SAM 350P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 360P SAM360P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 360P SAM360P
FDA UDI
Class IIIActive
Pad-Pak Pad-Pak-07
FDA UDI
Class IIIActive
Pediatric-Pak Pad-Pak-02
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 350P SAM 350P
FDA UDI
Class IIIActive
samaritan PAD SAM 350P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 360P SAM 360P
FDA UDI
Class IIIActive
samaritan PAD SAM 450P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 450P SAM450P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 450P SAM450P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 450P SAM450P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 350P SAM350P
FDA UDI
Class IIIActive
HeartSine Samaritan PAD 350P SAM 350P
FDA UDI
Class IIIActive
Pad-Pak Pad-Pak-01
FDA UDI
Class IIIActive
Pediatric-Pak Pad-Pak-02
FDA UDI
Class IIIActive
Saver EVO 1.4.0
FDA UDI
Class IIIActive
Reduced Energy Pediatric Electrode Pads For The Samaritan Aed And Pad, Models Sde 251, Spp 351 K052465
FDA 510(k)
Class IIIActive
samaritan PAD 450P K142709
FDA 510(k)
Class IIIActive
Heartsine Samaritan Pad K041067
FDA 510(k)
Class IIIActive
Samaritan Aed, Model Sam-01 K023854
FDA 510(k)
Class IIIActive
Heartsine Samaritan Pad 350p K123881
FDA 510(k)
Class IIIActive
Samaritan Pad Pak Defibrillation Electrode, Model Spp-301 K042088
FDA 510(k)
Class IIIActive
samaritan Public Access Automated External Defibrillators and Accessories P160008
FDA PMA
Class IIIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Oct 5, 2005Z-1046-05—terminated

Immediately after battery installation the devices announce a low battery fault warning and shut themselves off, or the service indicator icon starts blinking indicating a fault condition.

Feb 14, 2005Z-0641-05—terminated

The affected Automatic External Defibrillators (AED) annouce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are interpreted by the AED software as a fault condition.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Heartsine Technologies, Ltd BELFAST Northern Ireland · GB FEI 3004123209